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Over-The-Counter (OTC) Hearing Devices: What You Need to Know Today
March 14, 2023
What you need to know about over-the-counter hearing devices

For several years, modifications on how hearing devices are classified have been in the works. Keeping abreast of updates can be challenging since misinformation abounds on the topic. Below you will find background information as well as the most recent updates since the FDA guidelines were released in August 2022.


Two categories of hearing devices historically
Historically, two types of hearing devices were categorized—hearing aids and personal sound amplification products, or PSAPS.  


Hearing aids
For years, programmable hearing aids have been classified by the U.S. Food and Drug Administration (FDA) as Class I or Class II medical devices. The difference between Class I and Class II hearing aids is that Class II hearing aids are those that integrate wireless technology, including ear-to-ear communication and Bluetooth. In order to be fit with one of these Class I or Class II hearing aids, a patient would see a licensed hearing care professional, namely an audiologist or a hearing aid dispenser. The hearing care professional conducts a diagnostic hearing test to determine the level of hearing loss, takes measurements and/or custom earmolds, and fits the person with hearing aids based on a thorough review of the person’s unique hearing loss, common listening environments, and other needs. During the fitting process, live measurements are made while the hearing aids are in the patient’s ear with the hearing care professional using the hearing manufacturer’s computer software to minimize feedback and adjust for optimal sound quality. Additionally, real-ear measurements are used to verify targets are met to insure the person is receiving proper amplification.


Personal Sound Amplification Products, or PSAPS
Available for many years and often confused with hearing aids are PSAPs, or personal sound amplification products, that are available in retail stores and through purchase online, by mail order or over the phone. PSAPs are not hearing aids. Instead, they amplify all sounds without discernment and, therefore, are not intended for those with hearing loss. Devices for those with hearing loss need to be tailored and programmed to an individual’s specific needs. Because of the low cost of PSAPs (anywhere from $10 to $500), many have sought to treat their hearing loss with these devices, however. Historically, the FDA has differentiated between hearing aids and PSAPs as a way of protecting consumers from the potential damage that PSAPs can do to a person’s hearing since the devices can be purchased without a prescription and without a hearing evaluation or ongoing care from a trained hearing care professional.


Changes in 2017 that initiated the redefinition of hearing devices
In 2017, two pieces of Congressional legislation were passed that significantly impact hearing devices—the FDA Reauthorization Act and the Over-the-Counter Hearing Aid Act


FDA Reauthorization Act of 2017
The FDA Reauthorization Act was signed into law in 2017. This sweeping act included revisions and extensions for things like user-fee programs for drugs, generic drugs, and other similar biological products. It also included revisions for medical devices, thus opening the door for a third category of hearing devices—an over-the-counter category.  The Act outlines that the new OTC class of hearing products are for people with “self-perceived mild-to-moderate hearing loss.” OTC devices will be available without a prescription or the involvement of a licensed professional for fitting and programming the hearing aids.


Over-the-Counter (OTC) Hearing Aid Act of 2017
The OTC Hearing Aid Act of 2017 was also signed into law in 2017 and is a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the FDA that is available directly to consumers without involvement from a licensed professional like an audiologist or otolaryngologist.


FDA rules for this new class of hearing aid were expected to be released by the end of 2020, but a delay was announced noting the COVID-19 pandemic as the overarching factor for delay. However, further delay notices were forthcoming in March and April of 2021, pushing out the date when OTC regulations would be released by the FDA to the end of 2022. 


July 9, 2021 Executive Order
On July 9, 2021, President Joe Biden issued an executive order that included many health care related directives. The order included a directive to the Department of Health and Human Services, which oversees the FDA, to consider issuing the OTC hearing aid rules within 120 days of the order, or November 6, 2021.


August 16, 2022 FDA Releases OTC Regulations
On August 16, the FDA released a 200+ page document outlining the regulations for entities bringing products in this new class of hearing aid to the market. It outlines requirements as to the way labeling and packaging on these devices are presented to the public. It makes recommendations that OTC devices are for those with self-perceived mild to moderate hearing loss rather than profound hearing loss. The final rule also includes specifications as to the performance and device design of OTC hearing aids.


Things to Consider With OTC Hearing Aids
Audiologist resoundingly resist  OTC hearing aids. Here's why.


Recognizable brands as well as obscure companies will jump in the market and then out again based solely on profit margin rather than customer satisfaction. Examples abound of the mercurial nature of companies that jump into (and often out of) the direct-to-consumer hearing aid realm, and the overarching reason tends to be lack of profit margin. One company that is well known for its home stereo systems and speakers jumped into the market with an OTC hearing aid stamped with their logo and then stepped out of the market just 10 months later, and this was before the FDA guidelines were even released. They then aligned themselves with a company that has had a direct-to-consumer hearing product that has been available for years, stamped it with the new label that the FDA classification now allows, and presents it to the public as if it is something brand new.


It remains to be seen what other devices will trickle into the OTC realm ultimately. No doubt, it will include a wide range of products that may be difficult for consumers to gauge the usefulness and safety of, despite the FDA's aim to monitor new devices. Using the term hearing aid to describe what will likely be distributed in the OTC market may be misleading, at best, and dangerous at worst, to the public welfare. How so?


Hearing loss is a health issue not a retail experience
Hearing loss and other disorders of the ear are health concerns, and should, thus, be diagnosed and treated by an audiologist, the university-trained health care provider with education, training and certification in conditions involving the ear and hearing. If a person has a heart condition, he seeks out a cardiologist. If a person has diabetes, she visits an endocrinologist. A person with hearing loss and other hearing disorders, like tinnitus and hyperacusis, should be treated by an audiologist or otolaryngologist, the health care providers most qualified to diagnose and treat hearing loss.


Self-fitting and self-programming a recipe for failure
OTC hearing aids are designed to be self-fitting and self-programming, and FDA regulations specify they are for those with perceived mild to moderate hearing loss. Predictions are that many companies will enter the market with devices where programming is based on an at-home hearing test or no hearing test at all. Questioning on these companies' website even asks potential customers to rate their own level of hearing loss. These scenarios can produce highly varied and potentially inaccurate hearing loss measures and, thus, can lead to ill-fit and ill-programmed hearing devices, which could translate into  low customer satisfaction and the danger of a person giving up on hearing aids completely because they feel like they "don't work."  This robs a person of the vast benefits they realize when they have hearing loss that is properly diagnosed and hearing aids that are properly fit and programmed. They also miss out on the ongoing support and care an audiologist provides.


Diagnoses of more serious health issues may be missed
Audiologists are often a patient’s first line of defense in detecting disease process, acoustic tumor, cerumen impaction, eardrum issues, balance disorders, etc. Hearing loss can result from a myriad of factors. Bypassing qualified hearing professionals for an OTC option may mean that a serious condition goes undetected and untreated.


Hearing loss on the rise worldwide
Hearing loss is on the rise worldwide, further punctuating the necessity for qualified professionals to treat this growing public health concern. Interestingly, political entities use the increase in hearing loss as an argument in favor of OTC hearing aids, reasoning that OTC will offer people greater accessibility to hearing devices. Again, an inaccurately fit and programmed hearing aid, however “accessible,” does not lead to better outcomes, but rather to frustration and attrition.


Measuring the cost of OTC hearing devices
Political entities site cost as an overarching factor for the need for OTC hearing aids; yet, closer examination reveals that price gouging on hearing aids has much more to do with the hodgepodge of legal dispensing entities that have been allowed by the government to enter the hearing aid arena. At Johnson Audiology, we implore people to educate themselves on which entities that can dispense hearing aids, albeit legally, are the actual culprits in price gouging. Audiologists earn a doctoral degree from an accredited university, they devote years to their education while in school and beyond, and are bound by strict ethics in the way they treat patients and dispense hearing aids. Other types of dispensing entities, however, like big box store hearing aid counters and franchise hearing aid dispensers do not necessarily operate under that same ethical code. One could argue that OTC, a retail-based dispensing entity, will likely fall into the same category—more interested in selling hearing devices than helping people be successful on a lifelong journey to healthier hearing. And while the cost may appear cheaper up front for OTC hearing aids, spending less money on a hearing device that provides limited benefit is actually less cost effective in the long run. Reputable audiologists, on the other hand, are committed to offering information and access to a wide range of support options for patients who cannot afford hearing aids. Many audiology practices commit time and human resources in working with patients’ insurance companies and third-party hearing aid plans, despite low reimbursement rates for many services. They work with Veterans by way of the VA, which offers hearing aid benefits, and they help individuals with special needs acquire hearing devices by way of state Vocational Rehabilitation programs. They put patients in touch with non-profit groups, like Easter Seals’ and Lions Club International’s hearing programs, that provide help for hearing health care, all in an effort to get people hearing again. In 2019, Johnson Audiology launched its own non-profit organization to help those in need get hearing aids, the Johnson Audiology Hearing Foundation. Learn more at www.johnsonaudiology.com/foundation.


As additional information continues to be available about OTC hearing devices, Johnson Audiology will provide further updates.

Cochlear implantation: A game changer for Chattanooga native, Chipper Gocke

March 6, 2025
Chipper Gocke, 28, has had many poignant moments in the last six weeks since his cochlear implant surgery. “A workmate commented recently that my speaking voice is the appropriate volume now. Not being able to hear myself, I probably often talked too loud before. It seems like a small thing, but it is a way to be more normalized in my professional and other settings.” His mother, Amy Gocke, also has noticed the changes. “Chipper has never called me on the phone before. With his profound lifelong hearing loss and even using powerful hearing aids, he simply couldn’t communicate by phone. Now I look forward to his calls every day after he gets off work.” These daily experiences that people often take for granted—communicating with a workmate or calling a family member to say hello—are now possible for Chipper because of his cochlear implant. Hearing loss has been a part of Chipper’s life since he was a small child. Chipper’s father, Ted Gocke, relates, “From the time he was 18 months old, Chipper had ear infections that had us in and out of the hospital. That led to tubes in his ears and the diagnosis that he had a significant hearing loss.” As a youngster, Chipper received early intervention services before he even reached school age. He also got established with local audiologist, Darnell Scafe, and they reconnected recently when Chipper sought out Darnell for hearing health care services as an adult. Darnell, who joined the Johnson Audiology team in 2018, says, “I remember Chipper as a sweet little boy who didn’t let his hearing loss slow him down. It’s wonderful to get to know the fine, capable young man he has grown into.” Last year, Darnell encouraged Chipper to consider a cochlear implant, and she referred him to Johnson Audiology’s Cochlear Implant Program Director, Dr. Hannah Dearth. Dr. Dearth then was able to complete cochlear implant candidacy testing. In November of last year, Chipper’s surgery was performed at Murfreesboro Medical Clinic (MMC) in Middle Tennessee by an otolaryngologist (ENT). A native of Chattanooga, Chipper traveled for the initial surgery since there is not currently an ENT in Chattanooga who performs CI surgeries. However, Chipper then had his cochlear implant activated at Johnson Audiology (JA) by Dr. Dearth in early January. Also, there to celebrate activation day was Darnell. “It felt like a full circle moment when Dr. Dearth activated Chipper’s cochlear implant, and he began to have those first sound perceptions.” Dr. Dearth explains, “People often wonder how a hearing aid and a cochlear implant are different. Cochlear implants are designed for patients whose hearing aids are no longer assisting them in understanding in both quiet and noisy environments. A hearing aid is designed to provide amplification for speech sounds that are unintelligible without said amplification. Cochlear implants are a surgical option for those who are no longer able to achieve meaningful understanding with a traditional hearing aid. Hearing aids rely on the ear’s natural pathway for hearing to accomplish this and so may not work well for someone with severe damage to the inner ear. A cochlear implant, on the other hand, bypasses the damaged parts of the ear by stimulating the auditory nerve directly with a mild electrical current that sends the sound signal to the brain.” Chipper is committed to his own success with his cochlear implant and in addition to listening to the speech of those around him, he is also tuning in to podcasts and audiobooks that give him even more speech exposure. Dr. Dearth says that is a huge factor in any patient’s ability to thrive with the device. “The patients who are committed to the aural rehabilitation as prescribed experience faster progress and higher success rates long term.” Chipper will continue regular follow-up appointments for the rest of his life to maintain successful progress with his CI. He gets emotional talking about the social isolation that can be a common side effect of profound hearing loss and, also, mentions the spatial awareness that better hearing offers. “Being able to pinpoint sound and localize stimuli from both sides of the head has positive effects for living a safe life,” Dr. Dearth says. Dr. Megan Johnson, audiologist, founder, and owner of JA, says, “Johnson Audiology has provided support for cochlear implant patients since 2017 with care offered through the practice’s location on Lee Highway in the East Brainerd area. After implantation, every other part of a CI patient’s hearing journey can be accomplished at Johnson Audiology—from initial activation to routine mapping.”  Chipper and his parents encourage people to explore the possibility of cochlear implants since it can make such a difference in a person’s daily life and function. Johnson Audiology is accepting new patients who currently wear hearing aids but would like to pursue cochlear implant candidacy as well as those who already have a cochlear implant. Call Johnson Audiology at 423.556.7185 or visit www.johnsonaudiology.com/schedule for more information or to schedule an appointment.

Untreated hearing loss is changing your brain

By Jan Hollingsworth • May 16, 2024
Research reveals that hearing loss actually rewires your neural pathways Your Amazing Brain Your brain is an amazing organ! This wrinkly, reddish-pink mass weighs about the same as your two-slice toaster, tipping the scales at about three pounds. Acting as a master control center, your brain enables every thought, breath, eye blink, heartbeat, movement—everything—that happens in your body. Rivaling the world’s most powerful supercomputer, your brain can download, process, and react in milliseconds to the tidal wave of information coming from your eyes, skin, nose, tongue, and ears. Neuroplasticity and Your Sense of Hearing Researchers have discovered that the human nervous system—made up of the brain, spinal cord, and a complex network of nerves—has incredible capacity to modify itself, both in function and physical structure. This is called neural plasticity . Dr. Megan Johnson, audiologist and owner of Johnson Audiology explains, “Neural plasticity is going gangbusters in a child’s brain as the child develops and matures into adulthood. Based on years of brain research, we also know that the adult brain is far from being fixed. It, too, changes and adapts when you learn new information or skills or as a response to stress, hormonal fluctuations, drug interactions, injury, and much more.” Dr. Johnson also relates that “your brain displays neuroplasticity when you experience hearing loss.” By measuring brain waves using an electroencephalograph, or EEG, scientists have studied how the brain of a person with hearing loss functions compared to a person with normal hearing. The results are both fascinating and sobering as studies reveal that, in those with hearing loss, the portion of the brain devoted to hearing becomes reorganized. This can be true even with early-stage, mild hearing loss, and the process happens quickly, often in months rather than years. The Hearing Center of Your Brain and Beyond What is actually happening when this takes place? Your brain has a right and a left hemisphere and six major lobes. Think of your frontal lobe as your brain’s boss, where executive functions like decision making, emotion and impulse control, and planning occur. Your temporal lobe, which contains the auditory cortex, is doing the heavy lifting when it comes to interpreting sounds and assigning those sounds meaning. The temporal lobe processes speech and language, and it is where initial learning of new information takes place, which is the first step for logging that information into memory. Dr. Johnson goes on to relate, “When the delicate infrastructure of your ear has become damaged through noise exposure, infection, etc. leading to hearing loss, your auditory cortex cries out to your frontal lobe, saying ‘Help! Help! I’m not receiving any sound to process, so I feel lost.’ The frontal lobe ‘boss’ jumps to attention, and your occipital lobe, responsible for processing vision and touch, takes over the areas in which hearing is normally processed. In other words, your other senses seek to compensate for the deficit due to the loss of your sense of hearing.” Amazing, right? So, where’s the rub? Picture a car assembly line; each worker has an assigned task. One day, the worker who installs the windshields is absent, and the worker who attaches the rearview mirrors is assigned double duty, and a duty that was not part of job training. It is easy to see how the worker left juggling both jobs is compromised, and a car might slip through minus a rear view mirror. Similarly, the areas of your brain that are being taxed to make up for a lack of hearing are overloaded and less able to do their assigned responsibilities. “This explains why so many of my patients with hearing loss relate feeling exhausted and frustrated after a big family gathering—where multiple talkers and sounds must be interpreted—rather than happy and invigorated by the experience. We call this listening fatigue ,” states Dr. Johnson. Additionally, when left untreated long enough, researchers point to the brain’s reorganization due to hearing loss as a significant correlation with dementia. Hearing Technology and Your Brain “But here's the great news!” Dr. Johnson says. When a person is fit with hearing aids or a cochlear implant and sound is restored, the brain has the ability to adjust back—partially or completely—to proper function. How swiftly that happens often depends on how long the hearing loss went untreated and is why she encourages patients to treat hearing loss sooner rather than later. “Here is what I tell patients who are downplaying the importance of hearing: If you won’t treat your hearing loss for the sake of your ears, do it for your brain!”
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